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381 Chronic obstructive pulmonary disease (COPD) is a progressive, life‐threatening respiratory disease that affects 210 million people worldwide includ‐ ing up to 82 million in Europe. Over the last de‐ cade, major clinical trials have allowed us to bet‐ ter refine our approach to clinical management and to solidify best practice with evidence‐based medicine. Bronchodilators remain the cornerstone of symptomatic treatment for all COPD severi‐ ty stages when administered on a regular basis to prevent or reduce symptoms and exacerba‐ tions.1‐3 Many national and inter national guide‐ lines suggest using either a long‐acting β2‐agonist (LABA) or long‐acting antimuscarinic (LAMA) to treat COPD. Because both are effective and con‐ venient, no guidance has been given on which one to choose if short‐acting agents fail to im‐ prove dyspnea.4 The COPD marketplace has also undergone a rapid evolution over the last decade with early adoption of these long‐acting bron‐ chodilators, i.e., monotherapy with tiotropium (LAMA), salmeterol, or formoterol (LABA), or alternatively with inhaled corticosteroids (ICS) as ICS/LABA combination therapy. In practice, most patients with symptomatic disease associ‐ ated with recurrent exacerbations are currently promptly established on triple therapy (LAMA along with ICS/LABA combination inhaler). Cur‐ rently available inhaled LABAs, such as salme‐ terol and formoterol, only provide bronchodila‐ tion for approximately 12 hours at recommend‐ ed doses, and hence they are administered twice daily when prescribed alone or as part of a com‐ bination inhaler with ICS. In September 2009, a new LABA medication for COPD, indacaterol (QAB149), from Novartis, Ba‐ sel, Switzerland, received positive opinion in Eu‐ rope from the Committee for Medicinal Products for Human Use supporting regulatory approval of the drug in the European Economic Area (EEA) as a once‐daily therapy. Two doses (150 and 300 μg) are currently being launched in many Europe‐ an markets with other regulatory authorities fol‐ lowing suit. In October 2009, the United States Food and Drug Administration, after reviewing the data, requested additional information on the dosing proposed for indacaterol before fur‐ ther considering approval. Indacaterol is a novel once‐daily, inhaled, ultra LABA (uLABA) that provides rapid and sustained 24‐hour improvement in airflow and hyperinfla‐ tion in patients with COPD. Clinical trials of up to a year’s duration have confirmed the suitabili‐ ty of indacaterol for once‐daily dosing, along with a favorable overall safety and tolerability profile for the maintenance treatment of COPD, at least in the European market.5,6 Indacaterol (Onbrez) via the Breezhaler deliv‐ ery system has an onset of action within 5 min‐ utes and a duration of bronchodilation of at least 24 hours. In doses of 150 and 300 μg (the ap‐ proved European dosage regimens), it has sus‐ tained benefits over 6 to 12 months with respect to both bronchodilation and patient‐reported outcomes. Dahl et al.5 described a large randomized con‐ trolled trial that compared 2 doses of indacater‐ ol (300 and 600 μg) given once daily vs. formot‐ erol 12 μg twice daily and placebo and reported data on efficacy, safety, and tolerability. The in‐ dacaterol regimens were statistically better than formoterol in the pulmonary function outcomes. It is inter esting that the superiority in lung func‐ tion over formoterol did not translate into a sig‐ nificant difference in clinical outcomes, i.e., the St George’s Respiratory Questionnaire, time to first exacerbation, days of poor control. Also it is important to further consider safe‐ ty and tolerability. Randomized controlled trials EDITORIAL

New once-daily, long-acting inhaled β2-agonist: what role will it play in the treatment of chronic obstructive pulmonary disease?